Drug Safety Associate

EDUCATION/EXPERIENCE/SKILLS:

Education:
* BS/BA degree in related discipline; or,
* MS/MA degree in related discipline; or,
* PhD in related discipline; or;
* BS or MS in Nursing, Pharmacy or other clinical degree, preferably in a health science field with a minimum of five years of clinical experience.
* Equivalent combination of education and experience.
* May require certification in assigned area.

Experience:
* Minimum of three years of experience with a Drug Safety database - Argus preferred
* Typically requires a minimum of five years of related experience and/or combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.

Knowledge/Skills/Abilities:
* Working knowledge of relevant FDA and ICH guidelines, and of regulations governing safety reporting and processing.
* Familiarity with Drug Safety database. Prior use of Argus preferred.
* Trained and proven proficiency in MedDRA.
* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
* Performs a variety of complicated tasks with some degree of creativity and latitude.
* Has good understanding and wide application of technical principles, theories, concepts and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
* Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.

JOB COMPLEXITY:
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* Creates formal networks involving coordination among groups.
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